Association of Biliary Tract Disorders in Chronic Kidney Disease Patients and Its Related Risk Factors

Our aim in this cross-sectional study is to determine the frequency and aspects of gallbladder dysfunction and the related risk factors in pre-ESRD and hemodialysis patients.

Study Overview

• Status: Not yet recruiting
• Conditions: CKD; Gall Bladder Dysfunction
• Intervention / Treatment: Diagnostic test: abdominal ultrasonography.

Detailed Description

Biliary tract disorders including cholelithiasis, cholecystitis, and other diseases of the biliary tract, are one of the most prevalent medical issues in the digestive system, posing a myriad of challenges for health workers and patients. Gallbladder dysfunction is the most frequent cause of symptomatic and complicated biliary tract disorders. Although gallbladder dysfunction is a common condition in Middle East countries, data on the incidence of end-stage renal disease (ESRD) are limited. The occurrence of gallbladder dysfunction in patients fed with low-protein diets suggests that gallbladder stones formation is affected by dietary protein content. Also the lithogenic composition changes of bile, increased nucleation tendency, and impaired motility of gallbladder are important factors in ESRD patients. It has been reported that chronic kidney disease (CKD) patients on regular hemodialysis (HD) have increased bile cholesterol levels and an increased bile saturation index. In addition, the gallbladder is innervated by the autonomic nervous system, which malfunctions in uremia, and it has been shown that gallbladder stasis might cause increased stone formation. In some studies, the prevalence of gallbladder dysfunction has been shown to increase in patients undergoing hemodialysis (HD) treatment for ESRD. So, we focused in this study to try to find association of gallbladder dysfunction in pre-dialysis ESRD and HD patient in comparison to normal renal function individuals.

• Study Type: Observational
• Enrollment (Estimated): 108

Contacts and Locations

• Study Contact: Name: Rehab Mohamed Mohamed Eltayeb, M.B.B.CH.; Phone Number: 01016644593; Email: rehab.eltaib@med.aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt
    • Faculty of Medicine Assiut University
    • Contact: Rehab Mohamed Mohamed Eltayeb Ahmed, M.B.B.CH.; Phone Number: 01016644593; Email: rehab.eltaib@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

individuals visiting outpatient clinics of nephrology, GIT and internal medicine in Assiut hospitals.

Description

Inclusion Criteria:

• Patients who are diagnosed as CKD with eGFR according to Cockcroft-Gault Equation, whatever they are on regular hemodialysis or pre-dialysis without history of previous gallbladder dysfunction with normal renal function individuals.

Exclusion Criteria:

• Patients who are younger than 18 years.
• Patients who are diabetic.
• Patients who have body mass index (BMI) more than 30.
• Patients who have family history of gallbladder disorder.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I; Gallbladder dysfunction in pre-dialysis CKD patients.	Diagnostic test: abdominal ultrasonography.; Evaluate the gallbladder ejection fraction (EF)
Group II; Gallbladder dysfunction in end stage CKD patients on dialysis.	Diagnostic test: abdominal ultrasonography.; Evaluate the gallbladder ejection fraction (EF)
Control Group; Gallbladder dysfunction in normal renal function participants (control group).	Diagnostic test: abdominal ultrasonography.; Evaluate the gallbladder ejection fraction (EF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gallbladder dysfunction in CKD patients	Evaluate the gallbladder ejection fraction (EF) which will be calculated by following formula. (EF = (fasting gallbladder volume (FV) - residual gallbladder volume (RV)) / fasting gallbladder volume (FV)x 100) EF = (FV - RV) / FV x 100	measuring fasting gallbladder volume (FV) after 10 overnight hours fasting and the residual gallbladder volume (RV) after 30 minutes after standard fixed meal

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: May 26, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: CKD; hemodialysis; gall bladder dysfunction; gall bladder ejection fraction
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Biliary Tract Diseases
• Other Study ID Numbers: Gallbladder dysfunction in CKD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No